This is a summary of the European public assessment report (EPAR) for Aloxi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aloxi.
Aloxi : EPAR - Summary for the public (PDF/77.12 KB)
First published: 13/03/2009
Last updated: 09/04/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Helsinn Birex Pharmaceuticals Ltd.
|Date of issue of marketing authorisation valid throughout the European Union||
26/04/2018 Aloxi - EMEA/H/C/000563 - II/0045/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Antiemetics and antinauseants
Serotonin (5HT3) antagonists
Aloxi is indicated in adults for:
- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
- the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Aloxi is indicated in paediatric patients 1 month of age and older for:
- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.